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  • PMS of Rekovelle shows ovarian hyperstimulation
  • by Lee, Hye-Kyung | translator Alice Kang | Feb 21, 2025 05:56am
post-marketing surveillance of Rekovelle Inj reveals ovarian hyperstimulation
MFDS plans to reflect the results of the reexamination to the label from the 28th
The reevaluation of Ferring Korea¡¯s fertility drug ¡®Rekovelle Prefilled Pen (follitropin delta)¡¯ revealed that 0.65% of patients experienced ovarian hyperstimulation syndrome, which is expected to be added as an adverse event.

The Ministry of Food and Drug Safety announced on the 20th the proposed changes to the licensed conditions following the re-examination of new drugs. A post-marketing surveillance was conducted on 611 patients over 4 years for the re-examination of Rekovelle in Korea.

As a result, the incidence of adverse events reported was 17.84% (109/611, 137 cases in total), regardless of causality. Among them, ovarian hyperstimulation syndrome occurred in 4 (0.65%) of 611 patients with serious adv
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